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June 1, 2021Lybalvi Approved to Treat Schizophrenia and Bipolar I Disorder
June 1, 2021 – The U.S. FDA has approved Lybalvi TM (olanzapine/samidorphan) tablets, manufactured by Alkermes, for the following indications for adult patients:
- To treat schizophrenia;
- For use alone to provide short-term (acute) or maintenance treatment of manic or mixed episodes that occur with bipolar I disorder; and
- For use in combination with valproate or lithium to treat manic or mixed episodes that occur with bipolar I disorder.
Schizophrenia interferes with a person’s thoughts, behavior, and emotions. Signs and symptoms may include hallucinations, delusions, disorganized thinking and speech, abnormal motor behavior, and trouble carrying out day-to-day activities and social interactions such as maintaining proper hygiene and making eye contact.
Bipolar I disorder is a subtype of bipolar disorder. It is characterized by the experience of at least one manic episode followed by hypomania or depression. Mania and hypomania are mood disturbances that can cause intense emotion. Mania is more severe, lasts for a week or more, and has a significant negative impact on a person’s ability to maintain day-to-day function. Hypomania typically lasts for only a few days, and while it may affect a person’s regular activities, it tends to be more manageable than mania.
In a clinical study, Lybalvi demonstrated antipsychotic efficacy, safety, and tolerability. The drug combines olanzapine – an already FDA-approved treatment for schizophrenia and bipolar I disorder – with samidorphan, an active pharmaceutical ingredient intended to help reduce weight gain side effects associated with olanzapine. In a clinical trial, the participant group taking Lybalvi had a lower mean percent weight gain from baseline at six months than the olanzapine-only group. Fewer patients on Lybalvi gained 10% or more of their baseline body weight at six months than those on olanzapine alone.
Recommended dosing is one tablet per day, with the dosage strength based on the indication and on patient response to therapy. For treatment of schizophrenia, daily dosage strength may vary from a minimum of olanzapine 5mg/samidorphan 10mg to a maximum of olanzapine 20mg/samidorphan 10mg. Daily dosage strength for bipolar I disorder can range from olanzapine 10mg/samidorphan 10mg to a maximum of olanzapine 20mg/samidorphan 10mg.
Lybalvi is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Samidrophan is an opioid antagonist that blocks the effect of opioids and could contribute to withdrawal symptoms, reduced pain relief, and opioid overdose. A black box warning cautions that Lybalvi is not approved for the treatment of patients with dementia-related psychosis, as antipsychotic drugs are associated with increased mortality in elderly patients who have dementia.
Alkermes plans to launch Lybalvi during the fourth quarter of 2021. Pricing is not yet available.